Системи якості у фармації: мультидисциплінарний контекст державної фармакопеї України

Oleksandr Gryzodub, V. Shapovalov
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引用次数: 10

Abstract

The multidisciplinary context of the State Pharmacopoeia of Ukraine in drug quality systems was justified through an interdisciplinary study of pharmaceutical business organization, quality control, standardization, drug technology, management, marketing, forensic pharmacy, medical and pharmaceutical law in the system of legal relations "doctor-patient-pharmacist-lawyer" during state formation and implementation of Ukraine's integration processes into the WTO and the EU. Noted that the State Pharmacopoeia of Ukraine was from the first of the CIS countries, fully harmonized with the European Pharmacopoeia, takes into account national specificities, the Constitution of Ukraine, legislation on normative legal acts of Ukraine. Proven that, according to international assessments, the State Pharmacopoeia of Ukraine is the best National Pharmacopoeia in the post-Soviet space concerning the modern requirements of the WTO and WHO regarding quality and safety systems of medicines.
乌克兰国家药典在药品质量体系中的多学科背景是通过在国家形成和实施乌克兰加入世界贸易组织和欧盟一体化进程中对制药企业组织、质量控制、标准化、药品技术、管理、营销、法医学、医疗和药理学法律关系系统中的“医生-患者-药剂师-律师”的跨学科研究来证明的。注意到乌克兰的国家药典是来自独联体国家中的第一个国家,与欧洲药典完全协调,考虑到国家特点、乌克兰宪法、乌克兰规范性法律行为的立法。事实证明,根据国际评估,乌克兰国家药典是后苏联时代关于世界贸易组织和世界卫生组织关于药品质量和安全系统的现代要求的最好的国家药典。
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